Articulating suturing device and method

ABSTRACT

Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot is inserted through a penetration and actuated extend the foot carrying suturing attachment cuffs. Needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cuffs lockingly engage the needles and can be withdrawn along the needle paths and through the tissue tract to form a loop of suture across the puncture. The articulating foot may be realigned with the shaft and withdrawn proximally through the tissue tract without dilating the tissue tract.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation application of application Ser. No. 10/652,182,filed Aug. 23, 2003, which is a continuation-in-part of and claims thebenefit of priority from application Ser. No. 10/357,984, filed Feb. 4,2003, which is a continuation-in-part of application Ser. No.10/152,272, filed May 20, 2002, now U.S. Pat. No. 6,964,668, which is acontinuation-in-part of application Ser. No. 09/651,344, filed Aug. 29,2000, now U.S. Pat. No. 7,001,400, which is a division of applicationSer. No. 09/262,402, filed on Mar. 4, 1999, now U.S. Pat. No. 6,136,010.The disclosures of application Ser. Nos. 09/651,344, 10/152,272,10/652,182 and 10/357,984, as well as U.S. Pat. Nos. 6,136,010,6,964,668, and 7,001,400 are hereby incorporated herein by thisreference.

BACKGROUND OF THE INVENTION

The present invention relates generally to apparatus and methods for thesuturing of body lumens. More particularly, the present inventionrelates to techniques for percutaneous closure of arterial and venouspuncture sites, which are usually accessed through a tissue tract.

A number of diagnostic and interventional vascular procedures are nowperformed translumenally. A catheter is introduced to the vascularsystem at a convenient access location and guided through the vascularsystem to a target location using established techniques. Suchprocedures require vascular access, which is usually established duringthe well-known Seldinger technique, as described, for example, inWilliam Grossman's “Cardiac Catheterization and Angioplasty,” 3^(rd)Ed., Lea and Febiger, Philadelphia, 1986, incorporated herein byreference. Vascular access is generally provided through an introducersheath, which is positioned to extend from outside the patient body intothe vascular lumen.

When vascular access is no longer required, the introducer sheath isremoved and bleeding at the puncture site stopped. One common approachfor providing hemostasis (the cessation of bleeding) is to applyexternal force near and upstream from the puncture site, typically bymanual or “digital” compression. This approach suffers from a number ofdisadvantages. It is time consuming, frequently requiring one-half houror more of compression before hemostasis is assured. Additionally, suchcompression techniques rely on clot formation, which can be delayeduntil anticoagulants used in vascular therapy procedures (such as forheart attacks, stent deployment, non-optical PTCA results, and the like)wear off. This can take two to four hours, thereby increasing the timerequired before completion of the compression technique. The compressionprocedure is further uncomfortable for the patient and frequentlyrequires analgesics to be tolerable. Moreover, the application ofexcessive pressure can at times totally occlude the underlying bloodvessel, resulting in ischemia and/or thrombosis. Following manualcompression, the patient typically remains recumbent from four to asmuch as twelve hours or more under close observation so as to assurecontinued hemostasis. During this time renewed bleeding may occur,resulting in blood loss through the tract, hematoma and/orpseudo-aneurysm formation, as well as arteriovenous fistula formation.These complications may require blood transfusion and/or surgicalintervention.

The incidence of complications from compression-induced hemostasisincreases when the size of the introducer sheath grows larger, and/orwhen the patient is anticoagulated. It is clear that the compressiontechnique for arterial closure can be risky, and is expensive andonerous to the patient. Although the risk of complications can bereduced by using highly trained individuals, dedicating such personnelto this task is both expensive and inefficient. Nonetheless, as thenumber and efficacy of translumenally performed diagnostic andinterventional vascular procedures increases, the number of patientsrequiring effective hemostasis for a vascular puncture continues toincrease.

To overcome the problems associated with manual compression, the use ofbioabsorbable fasteners or sealing bodies to stop bleeding haspreviously been proposed. Generally, these approaches rely on theplacement of a thrombogenic and bioabsorbable material, such ascollagen, at the superficial arterial wall over the puncture site. Whilepotentially effective, this approach suffers from a number of problems.It can be difficult to properly locate the interface of the overlyingtissue and the adventitial surface of the blood vessel. Locating thefastener too far from that interface can result in failure to providehemostasis, and subsequent hematoma and/or pseudo-aneurysm formation.Conversely, if the sealing body intrudes into the arterial lumen,intravascular clots and/or collagen pieces with thrombus attached canform and embolize downstream, causing vascular occlusion. Also, thrombusformation on the surface of a sealing body protruding into the lumen cancause a stenosis, which can obstruct normal blood flow. Other possiblecomplications include infection, as well as adverse reaction to thecollagen or other implant.

A more effective approach for vascular closure has been proposed in U.S.Pat. Nos. 5,417,699, 5,613,974; and PCT published Patent Application No.PCT/US96/10271 filed on Jun. 12, 1996, the full disclosures of which areincorporated herein by reference. A suture-applying device is introducedthrough the tissue tract with a distal end of the device extendingthrough the vascular puncture. One or more needles in the device arethen used to draw suture through the blood vessel wall on opposite sidesof the puncture, and the suture is secured directly over the adventitialsurface of the blood vessel wall to provide highly reliable closure.

While a significant improvement over the use of manual pressure, clamps,and collagen plugs, certain design criteria have been found to beimportant to successful suturing to achieve vascular closure. Forexample, it is highly beneficial to properly direct the needles throughthe blood vessel wall at a significant distance from the puncture sothat the suture is well anchored in the tissue and can provide tightclosure. It is also highly beneficial to insure that the needledeployment takes place when the device is properly positioned relativeto the vessel wall. The ease of deployment and efficacy of the procedurecan further be enhanced by reducing the cross-section of that portion ofthe device which is inserted into the tissue tract and/or the vesselitself, which may also allow closure of the vessel in a relatively shortamount of time without imposing excessive injury to the tissue tract orvessel.

For the above reasons, it would be desirable to provide improveddevices, systems, and methods for suturing vascular punctures. Suchdevices would have the capability of delivering a pre-tied knot to anincision site. It would be particularly beneficial if these improveddevices provided some or all of the benefits while overcoming one ormore of the disadvantages discussed above.

DESCRIPTION OF THE BACKGROUND ART

U.S. Pat. Nos. 5,700,273, 5,836,956, and 5,846,253 describe a woundclosure apparatus and method in which needles are threaded with sutureinside a blood vessel. U.S. Pat. No. 5,496,332 describes a wound closureapparatus and method for its use, while U.S. Pat. No. 5,364,408describes an endoscopic suture system.

U.S. Pat. No. 5,374,275 describes a surgical suturing device and methodof use, while U.S. Pat. No. 5,417,699 describes a device and method forthe percutaneous suturing of a vascular puncture site. An instrument forclosing trocar puncture wounds is described in U.S. Pat. No. 5,470,338,and a related device is described in U.S. Pat. No. 5,527,321. U.S. Pat.No. 5,507,757 also describes a method of closing puncture wounds.

BRIEF SUMMARY OF THE INVENTION

The present invention provides improved devices, systems, and methodsfor suturing of body lumens. The device often allows the suturing ofvascular puncture sites located at the distal end of a percutaneoustissue tract with greater ease, in less time, and with less patienttrauma than known systems. These improvements are generally providedthrough the use of shafts having smaller cross-sections than priorsuturing systems. In the exemplary embodiment, an elongate articulatedfoot near a distal end of a shaft is inserted through the penetrationand actuated so that the foot extends along the lumenal axis. The footcarries suture attachment cuffs, and can be drawn proximally up againstthe endothelial surface of the blood vessel. Needles are advanced fromthe shaft, through the vessel wall beyond the penetration, and intoengagement with the needle cuffs. The cross-section of the shaft withinthe tissue tract can be minimized by laterally deflecting the needlesbefore they leave the shaft, while tapered depressions within the footcan help guide the advancing needles into engagement with the cuffs. Thecuffs lockingly engage the needles so that the cuffs can be withdrawnproximally along the needle paths through the tissue tract so as to forma loop of suture across the puncture without having to thread theneedles directly with the suture inside the blood vessel. The sutureloop may be drawn distally from the shaft, proximally from within theblood vessel, or laterally down one of the needle paths, across thepuncture, and out the opposing path. Regardless, the articulating footmay be realigned with the shaft and withdrawn proximally through thetissue tract in a small profile configuration. The use of anarticulatable foot in combination with lateral deflection of the needlescan avoid dilation of the tissue tract, as was often necessary usingknown puncture closure systems.

In a first aspect, the invention provides a method for suturing apuncture through a vessel wall of a blood vessel. The puncture isdisposed within a tissue tract of a patient body, and the methodcomprises attaching a flexible filament to a first fitting. The firstfitting is inserted through the tissue tract and positioned adjacent thevessel wall, and a needle path is formed by advancing a first needlethrough the vessel wall. The needle is coupled with the first fitting,and the first needle, the first fitting, and at least a portion of thefilament are withdrawn through the vessel wall along the needle path.

First and second fittings will often be coupled to the flexiblefilament, and will generally be positioned so that the puncture isdisposed therebetween. The flexible filament will often comprise asuture extending between the first and second fittings, with eachfitting being drawn proximally by an associated needle so as to form thesuture loop. Alternatively, at least one of the needles may include adetachable tip and may advance a suture distally along the needle pathas the needle penetrates through the vessel wall. The flexible filamentcan again couple the first and second fittings, here allowing bothfittings to be withdrawn along a single needle path so that the sutureadvances down along the first needle path, laterally across thepuncture, and then out the other needle path.

Positioning of the fittings is generally effected by articulating anelongate foot within the blood vessel so that the foot extends along thevessel axis. A confirmation lumen may extend along a shaft supportingthe foot to ensure that the foot is positioned within the vessel priorto articulation. Once the foot is properly articulated, it can be drawnproximally to firmly engage the endothelial layer of the vessel. Thefoot will preferably include tapering depressions which direct theadvancing needle toward the fitting, and the suture or other flexiblefilament adjacent the fittings will often be releasably restrainedwithin a narrow slot extending from the depression. The suture or otherflexible filament and its associated slot will preferably be arranged toavoid entanglement of the advancing needle in the suture, and to ensurethat the fitting and suture can be withdrawn proximally as the needle isretracted. An atraumatic, flexible monorail guidebody may extend fromthe shaft and/or the articulatable foot to facilitate alignment of thefoot with the vessel, and also to help provide hemostasis while the knotis tied. A wide variety of foot articulation mechanisms may be provided,with deployment preferably being effected when the foot is disposedentirely within the vessel and using an actuator and foot motion thatavoid dilation of the puncture.

In another aspect, the invention provides a method for suturing anopening in a tissue. The method comprises inserting a distal end of aprobe through the opening, the probe defining a probe axis. An elongatedfoot of the probe is articulated so that first and second ends of thefoot extend laterally with the opening aligned therebetween. A firstneedle path is formed from the probe, through the tissue, and to thefirst end of the foot. A second needle path is formed from the probe,through the tissue, and to the second end of the foot. Suture isadvanced along the first and second needle paths to position a sutureloop across the opening.

In another aspect, the invention provides a method for suturing a bloodvessel. The vessel has a vessel wall, and the method comprises advancinga shaft toward the vessel wall. The shaft has an axis and a plurality ofneedle guides. A foot is deployed adjacent the vessel wall so that thefoot extends laterally from the shaft. A plurality of needles areadvanced from the needle guides of the shaft to the foot to form needlepaths through the vessel wall. The needle guides deflect the needleslaterally so that a needle path width between the needles is greaterthan a cross-sectional dimension of the shaft. Suture is advanced alongthe needle paths to position at least one suture loop across thepuncture.

In yet another method of the present invention, a blood vessel issutured through a tissue tract of a patient body. The vessel has avessel wall, and the method comprises inserting a distal end of a probethrough the puncture and into the blood vessel. A first end of thesuture is advanced from the probe within the tissue tract, through thevessel wall, and into the vessel. The first end of the suture iswithdrawn from the vessel through the vessel wall, and through a bightof the suture to form a loop of suture across the puncture. The firstend of the suture and a second end of the suture adjacent the bight aretensioned to detach the bight from the probe and form a knot affixingthe loop of suture across the puncture. Advantageously, the bight ofsuture may be pre-tied before the probe is inserted into the tissuetract, the bight optionally being releasably attached to the probe.

In a device aspect, the invention provides a system for suturing a bloodvessel. The vessel has a vessel wall, and the system comprises a needlehaving a proximal end and a distal end suitable for forming a needlepath through the vessel wall. The needle has a recessed engagementsurface adjacent the distal end. The system further comprises a flexiblefilament and a fitting attached to the filament. The fitting has anopening and a tab extending into the opening, the tab securinglyengaging the engagement surface when the needle advances through thevessel wall and into the opening, so that the fitting and at least aportion of the filament can be withdrawn proximally along the needlepath by the needle.

In a further device aspect, the invention provides a system for suturinga puncture of a blood vessel within a tissue tract. The vessel has avessel wall and defines an axis, and the system comprises a shaft havinga proximal handle and a distal end suitable for insertion along thetissue tract and into the vessel through the puncture. A foot is mountednear the distal end of the shaft. The foot has plurality of needlereceptacles extendable laterally from the shaft. A flexible filamentextends between the receptacles of the foot. A plurality of needles areadvanceable distally and laterally from the shaft, through the vesselwall outside the puncture, and to the receptacles of the foot.

In yet another device aspect, the invention provides a system forsuturing a puncture of a blood vessel within a tissue tract. The vesselhas a vessel wall, and the system comprises a shaft having a proximalhandle and a distal end suitable for insertion along the tissue tractand into the vessel through the puncture. A foot is mounted near thedistal end of the shaft. The foot has a first needle receptacle and isarticulatable from a small profile configuration to a large profileconfiguration by actuation of the handle. A first fitting is removablymounted adjacent the first needle receptacle. A filament is coupled tothe first fitting. A first needle is advanceable from the shaft to thefirst needle receptacle on the articulated foot. The first fittingsecurely engages the first needle so that the secured first fitting andat least a portion of the filament can be drawn through the vessel wallby the first needle.

In a still further device aspect, the invention provides a probe forsuturing an opening in a tissue. The probe comprises a shaft having aproximal end and a distal end and defining an axis therebetween. Theshaft has a size and configuration suitable for insertion through theopening in the tissue. An elongate foot is movably mounted to the shaft.An actuator extends along the shaft distally to the foot. Movement ofthe actuator slides the foot axially and pivots the foot from a lowprofile configuration to a deployed configuration extending laterallyfrom the shaft. A suture is supported by the foot, and a needle isadvanceable from the shaft, through the tissue, and to the deployedfoot.

In another aspect, the invention provides a suturing device having afirst penetrator and a second penetrator for suturing an incision. Thefirst penetrator is configured to form a first penetration about aperiphery of the incision. The first penetrator also carries a pre-tiedknot disposed about a periphery of the first penetrator for delivery tothe incision. The second penetrator is configured to form a secondpenetration about the periphery of the incision. The second penetratoralso includes suture disposed thereon that is drawn by the firstpenetrator through the first penetration and through the pre-tied knotduring retraction of the first and second penetrators from around theperiphery of the incision. The first penetrator draws the suture throughthe first penetration via a connection between the first penetrator andthe suture. Moreover, as the first penetrator draws the suture, thesuture delivers the pre-tied knot to the incision for closure of theincision.

In another aspect, the invention provides a suturing device for suturingan incision formed in an artery. The suturing device includes a firstpenetrator, a second penetrator and a receiver. The first penetrator,which forms a first penetration about a periphery of the incision,includes a pre-tied knot disposed about the first penetrator. The secondpenetrator, which forms a second penetration about the periphery of theincision, has suture disposed thereon, which refracts through the firstpenetration. The suture retracts through the first penetration into thepre-tied knot during retraction of both the first penetrator and thesecond penetrator from around the periphery of the incision. Inaddition, during refraction, the suture delivers the pre-tied knot tothe incision for suturing of the incision. The suturing device alsoincludes a receiver for receiving both the first penetrator and thesecond penetrator upon penetration formation. The receiver connects thesuture to both the first penetrator and the second penetrator and allowsretraction of the suture through the first penetration as the firstpenetrator and the second penetrator retract.

In another aspect, the invention provides a suturing device for suturingan opening of an artery of a patient during a surgical procedure. Thesuturing device includes a first penetrator, a second penetrator and afoot. The first penetrator is disposed about a periphery of the suturingdevice and the second penetrator is located opposite the firstpenetrator on the suturing device. The first penetrator includes apre-tied knot configured to receive suture releasably engaged with thesecond penetrator during suturing of the opening of the artery. Thefoot, which is movably coupled to the suturing device distal to thefirst penetrator and the second penetrator, includes a first cuff and asecond cuff. The first cuff and the second cuff, which couple to oneanother via a link, receive the first penetrator and a detachable end ofthe second penetrator respectively. The first and second penetratorspenetrate the artery at a proximal end of the suturing device and couplewith the first cuff and the second cuff upon penetration of the artery.The first and second penetrators couple with the first cuff and secondcuff such that during retraction of the first penetrator and the secondpenetrator from the artery, the suture delivers the pre-tied knot to theincision for closure of the incision.

In various aspects and embodiments of the invention described herein, apre-tied knot of suture is also included. The pre-tied knot mayinitially be positioned wrapped around an exterior surface of thedevice. Specifically, a length of suture having opposite ends and abight of suture therebetween is provided with the bight being disposedaround an exterior surface of the device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective of a percutaneous blood vessel closure deviceaccording to the principles of the present invention.

FIG. 2 illustrates the vessel closure device of FIG. 1 in which anelongate foot is shown in a deployed position.

FIGS. 2A-C illustrate actuation of a foot and advancement of needlesfrom a shaft to the articulated foot in a probe similar to the probe ofFIG. 1.

FIG. 3A is a detailed view showing the foot of the vessel closure deviceof FIG. 1 in a parked position prior to deployment.

FIG. 3B is a detailed view showing the foot of the vessel closure deviceof FIG. 1 in a deployed position.

FIGS. 4 and 4A are perspective views illustrating a suture attachmentcuff and an associated barbed needle for use in the vessel closuredevice of FIG. 1.

FIG. 5 is a cross-sectional view showing the barbed needles securinglyengaging the suture cuffs of the deployed foot.

FIGS. 6A-C illustrate one embodiment of a deployable foot, in which thefoot slides and pivots when drawn proximally by a tension member.

FIG. 7 illustrates the suture cuff positioned within a needlereceptacle, and also shows how the suture is releasably secured within aslot extending radially from the needle receptacle.

FIGS. 8A-C illustrate an alternative foot articulation mechanism inwhich lateral slots on the foot receive pins from the shaft to allow thefoot to pivot and slide axially.

FIGS. 9A and B illustrate a still further alternative foot actuationmechanism in which the foot slides axially within a slot.

FIGS. 9C and D illustrate a further foot actuation mechanism in whichrelative movement between the sides of a two-part shaft actuates thefoot.

FIGS. 10A-D illustrate alternative structures and techniques foravoiding entanglement of the needle with the suture.

FIGS. 11A-E illustrate an alternative closure system and method for itsuse in which a first needle advances the suture to the foot, while asecond needle engages and withdraws both the first and second suturecuffs, a flexible filament connecting the suture cuffs, and at least aportion of the suture from within the blood vessel so as to complete apre-tied knot.

FIGS. 12A and B illustrate an alternative probe having two pairs ofneedles and a foot with four needle receptacles so as to form two loopsof suture across a puncture of a blood vessel.

FIGS. 13A-G illustrate a method for use of a suture system so as toeffect hemostasis of a blood vessel puncture through a tissue tract.

FIGS. 14A and 14B are enlarged partial side views of a suturing devicein accordance with one embodiment of the present invention.

FIGS. 15A through 15F are enlarged cross-sectional views of theembodiment of the suturing device of FIGS. 14A and 14B.

FIGS. 16A and 16B are schematic views of a suture bight having apre-tied knot in accordance with one embodiment of the presentinvention.

FIGS. 17A through 17D show enlarged partial cross-sectional views of anembodiment of the suturing device in accordance with the invention, inwhich one embodiment of a penetrator tip and cuff engagement, penetratortip disengagement, and cuff ejection sequence is illustrated.

FIG. 18A is an enlarged partial cross-sectional view of an embodiment ofa foot in accordance with the present invention, showing the linkrouting through the suture bearing surfaces of the foot.

FIG. 18B is an enlarged partial cross-sectional view of an embodiment ofa device in accordance with the present invention, showing the linkrouting through a suture-bearing surface located distal to the foot.

FIGS. 19A and 19B are enlarged partial cross-sectional views of anembodiment of a foot in accordance with the present invention, showingan alternate penetrator tip and cuff engagement, penetrator tipdisengagement, and cuff ejection sequence.

FIGS. 20A through 20C are enlarged partial cross-sectional views of anembodiment of a foot in accordance with the present invention, showingan alternate penetrator tip and cuff engagement, penetrator tipdisengagement, and cuff ejection sequence.

FIG. 21 is an enlarged perspective view of an embodiment of the pre-tiedknot in accordance with the present invention.

FIGS. 22A through 22C show an alternate embodiment of a foot inaccordance with the invention.

FIGS. 23A through 23C show another alternate embodiment of a foot inaccordance with the invention.

FIGS. 24A and 24B are perspective views of an alternative embodiment ofa penetrator tip in accordance with the invention.

FIGS. 25A through 25C are schematic views of an alternate embodiment ofa vessel closure device in accordance with the present invention.

FIGS. 26A through 26D are schematic views of alternate embodiments of avessel closure device in accordance with the invention.

FIG. 27 shows a schematic view of one embodiment of a link and cuffassembly in accordance with the invention.

FIG. 28 shows a bight of suture wrapped on a mandrel to form a pre-tiedknot in accordance with the invention.

FIG. 29 illustrates one embodiment of a vessel closure device includinganother embodiment of a pre-tied knot.

FIG. 30 illustrates the suture pattern after the device of FIG. 29 hasbeen removed, showing the deployment of the pre-tied knot.

FIG. 31 illustrates another embodiment of a vessel closure deviceincluding another embodiment of a pre-tied knot.

FIG. 32 illustrates the suture pattern after the device of FIG. 31 hasbeen removed, showing the deployment of the pre-tied knot.

FIG. 33 illustrates another embodiment of a vessel closure deviceincluding another embodiment of a pre-tied knot.

FIG. 34 illustrates the suture pattern after the device of FIG. 33 hasbeen removed, showing the deployment of the pre-tied knot.

FIG. 35 is a partial perspective view illustrating a vessel closuredevice incorporating an embodiment of a pre-tied knot according to theprinciples of the present invention.

FIG. 36 is a partial perspective view illustrating a vessel closuredevice incorporating an embodiment of a pre-tied knot according to theprinciples of the present invention.

FIG. 37 is a close up view of the device of FIG. 36 showing details ofthe pre-tied knot.

FIG. 38 is a partial perspective view illustrating a vessel closuredevice incorporating an embodiment of a pre-tied knot according to theprinciples of the present invention.

FIG. 39 is a close up view of the device of FIG. 38 showing details ofthe pre-tied knot.

FIG. 40 is a schematic view of the suture bight pattern, developed intoa flattened presentation, of the device of FIG. 28.

FIG. 41 illustrates the suture pattern after the device of FIG. 38 hasbeen removed, showing the deployment of the pre-tied knot.

FIG. 42 is a perspective view illustrating a vessel closure deviceincorporating an embodiment of a pre-tied knot according to theprinciples of the present invention.

FIG. 43 is a close up view of the device of FIG. 42 showing details ofthe pre-tied knot.

FIGS. 44A-D illustrate the stages of deployment of the needles andsuture of the device of FIG. 42.

FIG. 45 is a perspective view illustrating a vessel closure deviceincorporating an embodiment of a pre-tied knot according to theprinciples of the present invention.

FIG. 46 is a close up view of the device of FIG. 45 showing details ofthe pre-tied knot.

DETAILED DESCRIPTION

Several embodiments of suturing device that delivers a pre-tied knot toa puncture or incision in a wall of tissue is disclosed. Various aspectsof such a device include a length of suture having a bight between firstand second ends of the suture. The bight includes one or more loops ofsuture that form a pre-tied knot when one or more ends of the suture areadvanced through the bight. The bight of suture may be prearranged inany of several configurations on the device.

Referring now to FIG. 1, a vessel closure device 10 generally has ashaft 12 having a proximal end 14 and a distal end 16. A proximalhousing 18 supports a needle actuation handle 20. A flexible, atraumaticmonorail guidebody 22 extends distally of distal end 16 of shaft 12.

As can be seen with reference to FIG. 2, a foot 24 is articulatablymounted near the distal end of shaft 12. Foot 24 moves between a lowprofile configuration, in which the foot is substantially aligned alongan axis of shaft 12 (as illustrated in FIG. 1), to a deployed position,in which the foot extends laterally from the shaft, upon actuation of afoot actuation handle 26 disposed on proximal housing 18.

FIGS. 2A through C illustrate the structure and actuation of foot 24 ofa preferred probe 10′ having a modified proximal housing, and also showhow needles 38 can be advanced distally from shaft 12 to the foot bydepressing needle actuation handle 20.

Actuation of foot 24 is illustrated more clearly in FIGS. 3A and B. Inthe parked position illustrated in FIG. 3A, foot 24 extendssubstantially along axis 28 of shaft 12. Note that the axis of the shaftneed not be straight, as the shaft may curve somewhat, particularlyadjacent the foot. In the exemplary embodiment, foot 24 is substantiallydisposed within a foot receptacle 30 of shaft 12 so as to minimize thecross-section of the device adjacent the foot prior to deployment.Advantageously, prior to deployment of the foot, device 10 can have across-section adjacent foot 24 of about 7 Fr or less, ideally having across-section of about 6 Fr or less for the entire device distally ofthe proximal end 14 of shaft 12.

Actuation of foot handle 26 slides a foot actuation wire 32 proximally,pulling foot 24 from a parked position to the deployed positionillustrated in FIG. 3B. Once deployed, a first end 24 a and a second end24 b of foot 24 extend laterally from the shaft. Suture 34 herecomprises a continuous filament with ends disposed in needle receptaclesadjacent each end of the foot. An intermediate portion of suture 34 mayextend proximally along a suture lumen of shaft 12 to and/or beyondproximal housing 18. Alternatively, in preferred probe 10′, the lengthof suture between the ends may extend distally within flexible guidebody22, preferably in a dedicated lumen (separate from the monorailguidewire lumen). In still further alternatives described below, a shortlength of suture or some other flexible filament may extendsubstantially directly between the needle receptacles

Shaft 12 also includes a foot position verification lumen that extendsdistally from a position verification port 36 to a position indicator athousing 18. When the foot is properly positioned within the bloodvessel, blood pressure will cause blood to flow proximally through theindicator lumen to the indicator. The indicator may optionally comprisea blood exit port, a clear receptacle in which blood is visible, or thelike. In the exemplary embodiment, the indicator of handle 18 comprisesa length of clear tubing extending from housing 18 (not shown) in whichthe blood is clearly visible. It should be understood that a widevariety of alternative position verifications sensors might be used,including electrical pressure sensors, electrolytic fluid detectors, orthe like

The structures used in positioning a loop of suture across the puncturecan be understood with reference to FIGS. 4, 4A, and 5. In generalterms, needles 38 extend from shaft 12 into secured engagement withfittings 40 attached to sutures 34. More specifically, needles 38include a barbed end 42 defining a recessed engagement surface 44.Fittings 40 are roughly cylindrical structures having an axial channel46 which receives barbed end 44 of needle 38 therein. A first slot iscut in fitting 44 so as to define at least one tab 48. Tabs 48 can beresiliently biased inward into channel 46. As needle 38 advances intofitting 40, barbed end 42 resiliently displaces tab 48 clear of channel46 so as to allow the barbed end to pass axially into the fitting. Oncebarbed end 42 is disposed axially beyond tab 48, the tab resilientlyflexes back into the channel, capturing needle 38 by engagement betweenthe tab and recessed surface 44. As each tab can hold the fitting inplace on the needle, the use of more than one tab increases thereliability of the system. Ideally, three tabs are provided, asillustrated in FIG. 4A.

To facilitate attachment of fitting 40 to suture 34, a second slot cutin the tubular fitting structure defines a suture attachment collar 50.Optionally, collar 50 may be crimped about suture 34 to mechanicallyaffix the suture to fitting 40. In addition and/or instead of mechanicalcrimping, suture 34 may be bonded to fitting 40 using an adhesive, heat,fasteners, knots, or the like.

Fitting 40 is quite small in size, and is generally configured tofacilitate withdrawing the fitting (and the attached suture) along withneedle 38 axially through the vessel wall along the needle path. Needle38 will generally have a cross-sectional width of between about 0.010inches and 0.020 inches. Barb 42 will extend laterally so as to definean engagement surface 44 having a protruding length of between about0.002 inches and 0.005 inches. Fitting 40 will preferably have across-sectional size roughly corresponding to or only slightly largerthan needle 38. Fitting 40 will typically have an outer lateral width ofbetween about 0.014 inches and 0.025 inches, and an axial length ofbetween about 0.035 inches and 0.050 inches. Channel 46 will be sized toreceive at least a portion of needle 38, and will generally have a widthof between about 0.010 inches and 0.020 inches. Suture 34 willpreferably extend axially opposite the open end of channel 46 so as tominimize drag when the suture is drawn proximally along the needle path.In the exemplary embodiment, needle 38 has a diameter of about 0.020inches, while the fitting comprises a tube having an outer diameter ofabout 0.020 inches, an inner diameter of about 0.016 inches, and anoverall length of about 0.047 inches. The fitting will typicallycomprise a resilient material, preferably comprising a metal, and in theexemplary embodiment, comprising stainless steel.

Needles 38 typically have a length of between about 5.0 inches and 6.0inches, and will preferably be sufficiently stiff to be advanced incompression through the vessel wall (and adjacent tissues) for up to 0.5inches when supported in cantilever. Nonetheless, the needles willideally be flexible enough to be laterally deflected within shaft 12, ascan be understood with reference to FIG. 5. Needles 38 generallycomprise a high strength metal, ideally comprising stainless steel.Fittings 40 will also preferably comprise a flexible material to allowtab 48 to flex out of the way of barbed end 42, and to resilientlyrebound and engage recessed surface 44. In the exemplary embodiment,barbed end 42 has a diameter of about 0.015 inches, with the diameter ofthe needle decreasing to about 0.008 inches proximally of the barb so asto define the recessed engagement surface.

As was generally described above, foot 24 includes needle receptacles 52adjacent the ends of the foot. A fitting 40 (with an associated end ofsuture 34) is disposed within each needle receptacle, and a surface ofthe receptacle tapers proximally and outwardly so as to guide theadvancing needles 38 into engagement with fittings 40 when foot 24 is inthe deployed position. As fittings 40 (and associated portions of suture34) are releasably supported in the foot, needles 38 can be withdrawnproximally so as to draw the fittings and suture ends from the footproximally into (and optionally through) shaft 12. The needlereceptacles of the exemplary embodiment taper outward at an anglebetween 20 and 35 degrees from the centerline of fitting 40, and thefitting is held in a recess having a diameter of about 0.0230 inches anda length of about 0.042 inches. A lateral opening or window through theside of foot to the fitting recess may be provided to facilitate needleand/or cuff positioning during assembly of the probe, and a protrudingcollar near the proximal end of the fitting recess may help keep thefitting in position.

FIG. 5 also illustrates the lateral deflection of needles 38 by needleguides 54 of shaft 12. This lateral deflection of the needles allows theuse of a small diameter shaft, while still encompassing sufficienttissue within the suture loop on opposite sides of the puncture so as toeffect hemostasis when the suture looped is tightened and secured. Inthe exemplary embodiment, shaft 12 comprises an outer casing of abiocompatible material such as stainless steel, carbon fiber, nylon,another suitable polymer, or the like. Needle guides 54 may be definedat least in part as lumens formed within the casing of a polymericmaterial such as nylon or the like. In some embodiments, shaft 12 maycomprise a carbon fiber filled nylon, or carbon fiber filled with analternative material.

One example of a suitable structure and articulation motion for foot 24is illustrated in FIGS. 6A and B. Foot actuation wire 32 (see FIG. 3A)rides in a lumen of shaft 12, and draws foot 24 from a parked position(shown in FIG. 6A) to a deployed position (shown in FIG. 6B) through acombination of sliding and pivoting of the foot. The foot remainssupported throughout its range of motion by arms disposed laterally oneither side of the foot, the arms defining (at least in part) footreceptacle 30. Once foot 24 is deployed, needle receptacles 52 and/orthe fittings disposed therein will preferably define a lateral suturingwidth 56 in a range from about 0.260 inches to about 0.300 inches. Foot24 may be machined or cast from a polymer or metal, but will preferablycomprise a polymer such as carbon fiber filled nylon. In some cases,foot 24 may be molded as two separate halves which can subsequently beaffixed together. Needles 38 advance from the fixed needle guides 54,and are laterally directed into fittings 40 by receptacles 52, asillustrated in FIG. 6C. In general, a shape memory alloy such asNitinol®. in its superelastic regime provides a particularlyadvantageous actuator wire for manipulating foot 24.

Referring now to FIG. 7, fittings 40 and suture 34 will be withdrawnproximally by the needles from needle receptacles 52. To releasablysupport fittings 40 and suture 34 and avoid entanglement of the suturein the needles, suture 34 is fittingly received within a slot 58 whichextends laterally from needle receptacles 52. As the needles pull thefitting axially from needle receptacles 52, suture 34 is pulled fromslot 58 and free from foot 24. Bending of the suture proximally withinthe suture slot can also locally increase the suture width, so that theinteraction between the bent suture and the slot can help hold thefitting in the recess

A wide variety of foot actuation mechanisms might be used within thescope of the present invention. A first alternative foot actuationarrangement is illustrated in FIGS. 8A-C. In this embodiment, a shaft 12i has pins 60 which ride in associated slots 62 of a foot 24 i. Proximalmotion of an actuation wire causes foot 24 i to move axially androtationally, with pins 60 sliding along slot 62, and the foot pivotingabout the pins. In this embodiment, guidebody 22 extends directly fromthe foot, as illustrated in FIG. 8C.

A still further alternative foot actuation mechanism is illustrated inFIGS. 9A and B. In this embodiment, slidable foot 24 ii is slidinglyreceived within a receptacle 30 of shaft 12 ii. Sliding of the foot 24ii from the parked position of FIG. 9A to the deployed position of FIG.9B places the needle receptacles 52 in the paths of needles from theshaft 12 ii without pivoting of the foot. Guidebody 22 (see FIG. 1) willextend here from a distal end of shaft 12 ii at a fixed angle from theshaft. Optionally, insertion through the tissue tract may be facilitatedby including an additional bend in the shaft axis adjacent the guidebodyon many embodiments.

Yet another foot actuation mechanism can be understood with reference toFIGS. 9C and D. Shaft 12 iii is formed in two parts, which slide axiallyrelative to each other when foot actuation lever 26 iii moves, using anoffset crank arrangement. A similar offset crank supports foot 24 iii,so that the sliding shaft parts cause the foot to pivot as shown.

A variety of features may be included in the articulatable foot, theneedle receptacle, and/or the needle to avoid tangling of the needle inthe suture as the needle is directed to the fitting. As illustrated inFIG. 10A, a moveable flap 64 may extend over slot 58 so that theadvancing needle slides along the flap toward the fitting, rather thanentering the slot and engaging the suture directly. Flap 64 may beaffixed along one side of the slot, with the other side of the flapflexing into the receptacle to release the suture from slot 58 when thefitting and suture are withdrawn by the needle.

An alternative mechanism for avoiding entanglement of the needle withthe suture is illustrated in FIG. 10B. In this embodiment, needlereceptacles 52 i have tangential slots 58 i which extends substantiallytangentially to the surface of the receptacle. As a result of thistangential arrangement, a needle entering the receptacle 52 i will bedirected toward the fitting contained therein, but will generally not beable to enter and advance within the tangential slot 58 i so as tobecome entangled with the suture. As illustrated in this embodiment, theslots may optionally extend laterally through the foot so that the loopof suture can be pulled from one side of the shaft without interference.

A still further alternative mechanism for avoiding entanglement betweenthe suture and the needle is illustrated in FIGS. 10C and D. Two-partneedle 38 i includes an outer sheath 66 and an inner core 68. The partsof these needles initially advance together into the receptacles withthe needle core 68 withdrawn so that the needle presents a smoothtapered tip (the combined tip preferably being larger in diameter thanthe slot containing the suture) as illustrated in FIG. 10C. Oncetwo-part needle 38 i is fully positioned within the needle receptacle,needle core 68 may extend axially to expose barbed tip 42 and recessedengagement surface 44 and to secure the needle to the fitting within theneedle receptacle. In the exemplary embodiment of FIGS. 4 and 5, barbedtip 42 is formed integrally with the rest of the needle structure, butthe tip has a larger cross-section than radial slot 58 containing thesuture 34. As a result, the barbed tip is unable to enter the slot,thereby avoiding entanglement between the needle and suture.

An alternative vessel closure probe 70 will be explained with referenceto FIGS. 11A through 11E. This embodiment includes an articulatable foot24 having a pair of needle receptacles 52, as described above. Althougheach needle receptacle 52 contains a fitting 40 for coupling a flexibleconnecting filament 74 to a tip of an associated needle, the connectingfilament 74 in this case comprises some temporary connecting filament,as shown schematically in phantom in FIG. 11A. The connecting filamentspans directly between the needle receptacles. Rather than pulling thetwo ends of an extended loop through the needle paths and proximally outthe tissue tract for tying, closure system 70 advances a single end ofthe suture distally along one needle path, across the puncture, and thenproximally along the other needle path. To provide this interaction, atleast one needle includes means for attaching suture 34 to connectingfilament 74, here in the form of a detachable coupling structure carriedon the at least one needle. This structure facilitates the use of apre-tied knot.

Referring now to FIGS. 11A and B, the distal end of probe 70 advancesdistally through skin S and into a tissue T of the patient while theprobe is in the small profile configuration with foot 24 aligned alongthe axis of the probe. Here, however, an end 76 of suture 34 is affixedto a detachable needle tip 78 of a hollow needle 38′. Detachable tip 78comprises a fitting having an opening receiving an end of suture similarto fitting 40, attached to a barbed needle end (similar to that ofneedle 38). Suture 34 may extend proximally within hollow needle 38where the needle has an open channel along its length, may exit thehollow needle just proximally of detachable tip 78, or may be disposedalongside a solid needle. Needle 38 (opposite hollow needle 38′) has afixed barbed tip, as described above, and a bight of suture 80 isreleasably attached to the probe shaft encircling the opening of needleguide 54 of the fixed tip needle. The bight of suture may be releasablydisposed within a slot of the probe, may be temporarily held in place bya weak adhesive or coating, or the like. A second end 82 of suture 34extends proximally along the shaft of the probe, the second end of thesuture optionally also being releasably held along the shaft.

Bight 80 will define a knot when first end suture passes therethrough,as can be understood with reference to FIGS. 11Ai and 11Aii. Bight 80will often include more than one loop, and may be pre-arranged so as todefine a square knot (using the layout schematically illustrated in FIG.11Ai), a clinch knot (FIG. 11Aii), or a variety of known or new surgicalknots.

Probe 70 advances along tissue tract TT to puncture P in blood vessel V.Once foot 24 is disposed within a blood vessel V, a pull wire moves thefoot proximally and pivots the foot laterally so that the foot extendsalong an axis A of the vessel, as illustrated in FIG. 11B. The foot canthen be pulled proximally against an inner surface of the vessel wall Wto ensure that the needle receptacles 52 are properly positioned

As can be understood with reference to FIGS. 11C and D, hollow needle38′ and needle 38 advance to engage fittings 40 within receptacles 52.Hollow needle 38′ draws first end 76 of suture 34 distally throughvessel wall W, and detachable tip 78 is secured into an associatedfitting 40 using the barb and tab interaction described above. Asconnecting filament 74 extends between fittings 40, and as detachabletip 78 can pull free of hollow needle 38′ when the needles arewithdrawn, this effectively couples needle 38 to first end 76 of suture34. The detachable tip riding partially within the hollow needle (orvice versa) so that the assembly remains together under compression.Hence, needle 38 can pull the suture distally along the needle pathformed by hollow needle 38′, across the puncture P, and proximally alongthe needle path formed by needle 38, as illustrated in FIG. 11D.

FIGS. 11D and E show that the knot can be completed by pulling needle38, connecting filament 74, and second end 76 of suture 34 (togetherwith the fittings 40 and detachable needle tip 78) proximally throughbight 80. Second end 82 of suture 34 can be pulled to free bight 80, andthe ends of the suture can be tightened and the probe removed to providepermanent hemostasis.

It will be recognized that removal of probe 70 can be facilitated bycoupling first end 76 to bight 80 over an outer surface of the probe,and by arranging suture 34 and hollow needle 38′ so that the suture canpull free of the needle when detachable tip 78 is released, for example,by having the suture exit the needle proximally of the tip through achannel that extends to the tip so that the needle does not encircle thesuture. By including such provisions, after foot 24 is returned to thenarrow configuration, the probe can be pulled proximally from the tissuetract leaving the pre-tied knot in place.

Alternative arrangements (using the detachable needle ends of probe 70)are possible to provide the benefit of a pre-tied knot and the like forclosure of a vessel puncture. For example, a probe having a pair ofneedles in which each needle included a detachable tip might be used topull first end 76 through a bight, so that the bight need not encirclethe needle path of one of the needles.

In some cases, particularly for closure of large punctures, it may beadvantageous to provide multiple suture loops across the puncture,either in parallel, in an “X” pattern, or the like. As illustrated inFIGS. 12A and B, the present invention encompasses the use of more thantwo needles and associated receptacles, fittings, sutures, and the like.Multiple loop systems may have four, six, eight, or more needles, or mayeven have odd numbers of needles and fittings, particularly where one ormore fittings have a plurality of suture ends extending therefrom. Thisallows a wide variety of stitching patterns to be provided by suchmultiple loop probes.

The method of use of the probes of FIGS. 1-7 can be understood withreference to FIGS. 13A-G. After accessing a blood vessel V (often usingthe Seldinger technique), a guidewire GW is left extending into skin Sand down through tissue T along tissue tract TT. Guidewire GW entersvessel V through a puncture P in vessel wall W, and extends along thevessel throughout many endovascular procedures. As illustrated in FIG.13A, distal guidebody 22 is advanced over the guidewire GW in a monorailfashion, so that the guidewire helps to direct the probe along thetissue tract TT and into the vessel through puncture P. FIG. 13B showsthat when sensor 36 is disposed within the vessel, blood can flow fromthe sensor port and through a lumen in shaft 12 to the proximal handleto notify the operator that foot 24 has been advanced far enough fordeployment.

Deployment of the foot is effected by actuation of the foot deploymenthandle, as described and illustrated above with reference to FIGS. 2 and2B. As described above, guidebody 22 helps to align the probe with theaxis of vessel V. Guidebody 22 may be set at an angle and/or offsetrelative to shaft 12 as appropriate to aid in alignment with aparticular vessel access technique. As shown in FIG. 13C, the deployedfoot 24 extends laterally from the shaft, so that foot 24 adjacentreceptacles 52 can be drawn up against vessel wall W by gently pullingshaft 12. Hence, the foot helps to accurately position the needle guides54 at a distance from the vessel wall.

Referring now to FIG. 13D, flexible needles 38 are deflected laterallyby needle guides 54 toward receptacles 52 of the deployed foot. As aresult, the needles advance in cantilever both distally and laterallywhen needle actuation handle 20 is pressed (see FIG. 2C), and thetapering surfaces of receptacles 52 help to push the needles back intoalignment with the fittings so as to overcome any unintended deflectionof the needles by tissue T or vessel wall W. This ensures that needles38 securingly engage fittings 40 within receptacles 52, thereby couplingthe ends of suture 34 to the needles. While suture 34 is hereillustrated running along the side of shaft 12 outside foot receptacle30 to a lumen within guidebody 22, it should be understood that thesuture loop might instead extend proximally in a lumen of shaft 12,might be routed through the foot and/or foot receptacle, and/or might bestored in a spool adjacent foot 24. Regardless, suture 34 should able topull free of the probe between its ends to form a continuous loop acrosspuncture P.

Referring now to FIGS. 13E and F, fittings 40 and the ends of suture 34are drawn proximally through the vessel wall W along the needle pathsformed by needles 38. Optionally, the needles may be withdrawnproximally out of the tissue tract and clear of shaft 12, or they mayremain coupled to the shaft within needle guides 54. The foot actuatoris moved to store foot 24 along shaft 12, and the shaft can then bepulled proximally from the tissue tract. Guidebody 22, which maycomprise a soft, compliant polymer, may temporarily extend at leastpartially into tissue tract TT and through puncture P to help reduce theloss of blood until the loop is secured.

Now referring to FIG. 13G, once shaft 12 has been withdrawn sufficientlyto expose needle guides 54, the ends of the suture loop can be graspedby the operator. Tying of a knot in suture 34 can then proceed in aconventional manner. The use of a clinch knot may facilitate gradualtightening of the knot while removing guidebody 22, although a widevariety of knot and knot advancing techniques might be used.

FIGS. 14A and 14B show an embodiment of a vessel closure device 100.This embodiment includes an articulatable foot 114 (FIG. 14B) having apair of penetrator receptacles (described below). Although eachpenetrator receptacle contains a fitting (or cuff) for coupling aflexible filament to a tip of an associated penetrator, the filament inthis case may be a short length of suture such as a link 112 spanningdirectly between the penetrator receptacles. Rather than pulling the twoends of an extended loop through the needle paths and proximally out thetissue tract for tying, closure system 100 advances a single end of thesuture distally along one needle path, across the puncture, and thenproximally along the other needle path. To provide this interaction, atleast one needle includes means for attaching suture 102 to the link112, here in the form of a detachable coupling structure carried on theat least one needle. This structure facilitates the use of a pre-tiedknot.

FIG. 15A shows a side, cross-sectional view of the device 100 in aposition prior to deployment of the foot 114. The device 100 has beenadvanced through the incision 105 in the arterial wall W. For ease ofdescription, reference numeral 122 indicates the anterior side of thedevice, and reference numeral 124 denotes the posterior side of thedevice. Device 100 has a rigid shaft 118 that has channels definedtherein to carry the elongate bodies or penetrators 106 and 106′.Penetrator 106′ may also be referred to as the anterior penetrator, andpenetrator 106 may be referred to as the posterior penetrator. Forpurposed of description and not limitation, the anterior penetrator 106′carries the pre-tied knot 104, and posterior penetrator 106 carries thedetachable coupling structure or penetrator tip 108. Anterior penetrator106′ defines a penetrator tip 108′ at its distal end.

The articulatable foot 114 includes anterior and posterior penetratorreceptacles 116′ and 116, respectively. These receptacles are alsoreferred to as cuff pockets. Cuffs 110 are shown positioned in cuffpockets 116′ and 116. A link 112 extends between the cuffs 110.

FIG. 15B shows the foot 114 deployed so as to position the cuff pockets116 to receive the first and second penetrators 106′ and 106. As shownin FIG. 15B, the anterior penetrator 106′ has the pre-tied knot 104disposed about a proximal portion of its length. Alternatively, thepre-tied knot 104 may be disposed about the periphery of a knot tube,through which the anterior penetrator 106′ may pass (as described infurther detail below).

FIG. 15B illustrates the suturing device 100 deployed within a lumen 107in accordance with an embodiment of the present invention. As may beseen with reference to the Figure, the suturing device 100 includes anelongate body 106′ having a penetrator tip 108′. The elongate bodies 106and 106′ deploy to form penetrations 109 and 109′ within the vessel wallW. The configuration of the penetrator tip 308 allows penetration of thevessel wall W immediately surrounding the incision 105 to form thepenetration 309. As such, the penetration of the penetrator tip 108through the tissue wall W allows for passage of the elongate body 106through the tissue and into the lumen 107. The elongate body 106 holdsthe suture 102 as the elongate body 106 passes through the tissue wall Wimmediately adjacent the incision 105 and into the foot 114.

As may be seen with reference to FIG. 15B, in this embodiment, the foot114 has a single unit design where the cuffs 110 and 110′ are disposedon opposite sides of the suturing device 100 and the foot 114. Thisorientation allows balance of forces during the deployment of theelongate bodies 106 and 106′, thereby allowing precise suturing andminimizing the possibility of incorrectly suturing the incision 105.Also, as may be seen with reference to the Figure, the suturing device100 delivers the suture longitudinally relative to the lumen 107,thereby minimizing arterial diameter constriction. Likewise, in thisembodiment, the foot 114 is positioned at an angle “Q” relative to theshaft 118 of the suturing device 100. Preferably, the angle “Q” is in arange between about 20 degrees and about 60 degrees and more preferablyis about 40 degrees. The angle “Q” approximates the puncture anglecommonly used to access the femoral artery. The angle Q and the rigidcharacter of the shaft 118 serve to provide accurate, virtuallysimultaneous “cuff capture” by both the anterior and posteriorpenetrators. Moreover, since the device 100 is preferably used withoutan introducer sheath, the rigid nature of the shaft 118 provides thecontrol of the travel of penetrators as they move distally to engage thecuffs. The device 100 can therefore be used in the same femoral arteryaccess puncture without disturbing the existing tissue tract and causingundue discomfort to the patient.

When both the elongate bodies 106 and 106′ and the suture 102 passthrough the lumen wall W and into the lumen 107, the elongate bodies 106and 106′ engage with the foot 114. The penetrator tip 108 and anteriorpenetrator tip 108′ of the elongate bodies 106 and 106′ engage withcuffs 110 and 110′ of the foot 114. The cuffs 110 and 110′ include alink 112 that connects the cuffs 110 and 110′ to one another. It shouldbe noted that the cuffs 110 and 110′ facilitate connection of thepenetrator tip 108 with the anterior penetrator tip 108′ such that thepenetrator tip 108 and the anterior penetrator tip 108′ are coupled toone another via the link 112.

FIGS. 16A and 16B show the suture bight in the pre-deployed state (FIG.16A) and the deployed state (FIG. 16B). The suture 102 is arranged toprovide the pre-tied knot 104 that automatically travels down from theshaft of the device where it is stored prior to delivery to the tissuewall. The loop 104 of suture 102 serves to pull the knot 104 down therail portion 140 of the suture during deployment. It should be notedthat it would be desirable to be able to distinguish the ends 140 and150 of the suture 102 during deployment so that the correct end ispulled by the operator to advance the knot. Should the non-rail end bepulled, the knot may be prematurely tightened before it is advance toits deployed position at the wall of the vessel.

The ends of the suture may be distinguished from each other by changingthe color of one end (e.g. with dye), providing an attachment on one end(e.g. shrink wrap tubing, a bead, etc.) or with the suture itself (e.g.tying a knot in one end).

FIG. 15C shows the penetrator tips fully deployed into and engaged withthe cuffs 110. FIG. 15D shows the penetrators being retracted after thetips have engaged the cuffs 110. On the anterior side 122, thepenetrator 106′ is pulling the anterior cuff 110 distally. On theposterior side 124, the penetrator tip 108 has been disengaged from thepenetrator 106, via a mechanism described below. As shown in FIG. 15D,the link 112 is now coupled to one end of the suture via posterior cuff110. Suture 102 is also shown exiting the posterior penetrator shank viaan opening in the side of the penetrator shank.

Referring to FIG. 15E, after deployment of the foot 114, the suture 102moves as indicated by directional arrows X1. As the suture 102 moves, asuture loop 103 also moves in a direction indicated by directional arrowX2 towards the foot 114 and the incision (not shown). The suture 102moves through the foot 114 and through an opening distal to the foot 114that defines a suture-bearing surface 111. The suture-bearing surface111 is disposed at a distal end of the suturing device 100 separate fromthe foot 114, in this embodiment. The suture bearing surface 111 bearsforces placed on the suture 102 during suturing. As such, thesuture-bearing surface 111 minimizes forces placed on an incision duringincision tensioning, thereby minimizing the possibility of damagingtissue immediately surrounding the incision. In this embodiment, thesuture bearing 111 is a slot disposed at a distal end of the suturingdevice 100, which includes a passage for the suture 102 during incisionsuturing as shown with reference to the Figure.

As the suture loop 103 and the suture 102 move, the pre-tied suture knot104 also moves in the same direction as the suture loop 103 towards thefoot 114 and the incision. The suture loop 103 continues to move thepre-tied suture knot 104 towards the incision until the suture 102 andthe pre-tied suture knot 104 suture the incision formed in the arterialwall. It should be noted that a suture trimmer might be used to assistthe delivery of the knot 104 to an arteriotomy. The suture trimmer maybe any device suitable for pushing the knot towards the arteriotomy andtrimming suture immediately adjacent the knot 104 once the knot istightened.

Now making reference to FIG. 15F, the suturing device 100 delivers thepre-tied suture knot 104 to the incision and the foot 114 is returned toits non-deployed position. The penetrators (not shown) have beenretracted, the link has been fully refracted through the knot, and theknot has been advanced to the vicinity of the arterial wall. When thebody of the device is removed, a stitch will remain in place across theincision in the artery. It should be noted that embodiments of thedevice described herein place a stitch of suture in a longitudinalorientation with respect to the vessel so as to minimize transversevessel constriction and also to take advantage of the transverseorientation of the fibers of the vessel tissue.

FIGS. 16A and 16B show the suture bight in the pre-deployed state (FIG.16A) and the deployed state (FIG. 16B). The suture 102 is arranged toprovide the pre- tied knot 104 that automatically travels down from theshaft of the device where it is stored prior to delivery to the tissuewall. The loop 104 of suture 102 serves to pull the knot 104 down therail portion 140 of the suture during deployment. It should be notedthat it would be desirable to distinguish the ends 140 and 150 of thesuture 102 during deployment so that the correct end is pulled by theoperator to advance the knot. Should the non-rail end be pulled, theknot may be prematurely tightened before it is advanced to its deployedposition at the wall of the vessel.

The ends may be distinguished from each other by changing the color ofone end (e.g. with dye), providing an attachment on one end (e.g. shrinkwrap tubing, a bead, etc.) or with the suture itself (e.g. tying a knotin on end).

FIG. 17A shows an enlarged detail of the posterior portion of the footof one embodiment of suturing device 300. In an accordance with anembodiment of the present invention, the elongate body 306 may be anytype of structure capable of penetrating the wall of a lumen, such as anartery, a blood vessel, or the like. In addition to the penetrationcapability, the elongate body 306 may be a hollow tube capable ofholding suture. Examples of such structures may include a hypodermicneedle or the like. The suturing device 300 stores the elongate body 306within its shaft (not shown). As previously described with reference toFIGS. 2A through 2C, a user deploys a handle (not shown) of the suturingdevice 300 thereby deploying the elongate body 306 and the penetratortip 308. During deployment, the elongate body 306 and the penetrator tip308 penetrate the lumen wall W immediately surrounding the incision 305and enter the lumen 307 of a patient, as shown with reference thefollowing FIG. 17B.

Once the penetrator tip 308 engages with the cuff 310, the elongate body306 and the penetrator tip 308, along with the cuff 310, proceed throughthe foot 314 and into the lumen 307. As may be seen with reference toFIG. 17B, the cuff 310 is pushed through the foot 314, such that thecuff 310 is pushed out of a pocket 316 and through the foot 314 into thelumen 307. Once the cuff 310 and the elongate body 306 enter the lumen307, the penetrator tip 308 detaches from the elongate body 306 via apush mandrel 315 as shown with reference to FIG. 17C.

FIG. 17C illustrates the detachment of the pentrator tip 308 from theelongate body 306 in accordance with one embodiment of the presentinvention. Upon engagement of the penetrator tip 308 with the cuff 310,the push mandrel 315 is further advanced such that it contacts aproximal surface 308 b of the penetrator tip 308, and further stilluntil the penetrator tip 308 detaches from the elongate body 306. Upondetachment of the penetrator tip 308 from the elongate body 306, thepush mandrel 315 and the elongate body 306 retract from the foot 314, asshown with reference to FIG. 17D.

As shown in FIG. 17D, after the penetrator tip 308 detaches from theelongate body 306, the elongate body 306 retracts from the penetratortip 308 and cuff 310. Meanwhile, on the anterior side of the device (notshown in FIG. 17D), the elongate body 306′ also includes the needle tip308′ which engages with the cuff 310′ as previously described withreference to FIG. 15C. The needle tip 308′ does not disengage from theelongate body 306′ upon engagement with the cuff 310′. Therefore, duringrefraction of the elongate body 306′ from within the lumen 307, theneedle tip 308′ also refracts from the lumen 307 through the penetration309′. As the needle tip 308′ retracts through the penetration 309′, theelongate body 306′ also retracts the cuff 310′. As previously described,the cuff 310′ couples with the cuff 310 via the link 312. Duringrefraction of the cuff 310′ through the penetration 309′, the cuff 310and the suture 302 also retract through the penetration 309′, therebydrawing the suture 302 through the penetration 309′. It should be notedthat the foot 314 may provide suture bearing surface for the suture 302during operation of the suturing device 300, as shown with reference toFIG. 18A.

FIG. 18A shows an embodiment of the present invention illustrating thepassage of the suture 302 through the lumen 307 and the passageways 309and 309′. As may be seen with reference to the Figure, the cuff pockets316 of the foot 314 provide a suture-bearing surface for the suture 302as the suture 302 is drawn through the passageways. The suture bearingsurfaces of the foot 314 minimize the possibility of the suture 302damaging tissue surrounding the incision 305.

In another embodiment shown in FIG. 18B, the suturing device 300 alsoprovides a suture bearing surface for the suture 302. During retractionof the elongate bodies 306 and 306′ from the lumen 307, the suture 302refracts through the foot suture bearing surfaces 314 a and thesuture-bearing surface 311 formed distally of the foot. The distalsuture bearing surface 311 and the foot suture bearing surfaces 314 aguide the suture 302 in order to minimize the possibility of the suture302 damaging the patient during retraction of the elongate bodies 306and 306′ from the lumen 307. In this embodiment, suture-bearing surface311 is a slot defined in the body of the device distal of the foot. Theslot includes a passage for the link and suture, and an edge 311 a. Itis contemplated that the edge 311 a may contact the edge of the incisionin the artery and become caught on the adventitia of the blood vessel.Various devices may be provided, such as flaps, o-rings, etc., thatprovide a smoother transition over the slot and edge 311 a as the deviceis inserted through the incision.

FIGS. 19A and 19B illustrate an alternative embodiment of the presentinvention for releasing the cuff 310 from the foot 314. In thisembodiment, the foot 314 includes link passageway 313 through which thelink 312 passes. After the elongate body 306 engages the penetrator tip308 with the cuff 310, the elongate body 306, during retraction from thefoot 314, removes the cuff 310 and the penetrator tip 308 from the foot314. The force holding the penetrator tip 308 on the elongate body 306overcomes the force holding the cuff 310 in the cuff pocket 316. Oncethe cuff 310 clears the foot 314 and attains the orientation shown withreference to FIG. 19B, the previously described push mandrel (not shown)detaches the penetrator tip 308 from the elongate body 306. Upondetachment of the penetrator tip 308 from the elongate body 306, thelink 312, along with the cuff 310 and the penetrator tip 308, retractsthrough the passageway 313 via the link 312 and the elongate body 306′.In an alternate embodiment, the cuff 310 and pentrator tip 308 may bepulled off the elongated body 306 by tension in the link 312.

In yet another alternate embodiment shown in FIGS. 20A through 20C, thecuff 310 and penetrator tip 308 may be detached from the elongate body306 before being removed from the cuff pocket 316. In this embodiment,after the elongate body 306 and the penetrator tip 308 engage with thecuff 310, the push mandrel 315 detaches the penetrator tip 308 from theelongate body 306, leaving it in the cuff pocket 316 to be removed bytension in the link 312, as shown in FIG. 20C.

It should be noted that other methods might be used to detach thepenetrator tip 308 from the elongate body 306. These methods include,but are not limited to, detachment through friction or tension. Makingreference to FIG. 20B, in an embodiment where friction between the cuffpocket 316 and the cuff causes detachment of the penetrator tip 308 fromthe elongate body 306, a surface 308 c of the penetrator tip 308frictionally engages with a cuff surface 316 a of the cuff pocket 316.During refraction of the elongate body 306 from the foot 314, thefrictional engagement between the cuff surface 316 a and the penetratortip surface 308 c causes detachment of the penetrator tip 308 from theelongate body 306. In an embodiment where link tension causes detachmentof the penetrator tip 308 from the elongate body 306, the link 312 istensioned such that the link 312 is taut between the cuffs 310 and 310′.As such, the tension of the link 312 prevents movement of the cuff 310out of the foot 314 along with the elongate body 306 during refractionof the elongate body 306 from the foot 314, thereby causing detachmentof the penetrator tip 308 from the cuff 310.

After detachment, during retraction of the elongate body 306 and theelongate body 306′ (not shown), the link 312 may draw the cuff 310 andthe penetrator tip 308 from the cuff pocket 316. As discussed earlier,the cuff 310′ engages with the elongate body 306′ and pulls the cuff 310via the link 312 as the elongate body 306′ refracts from the lumen 307.As such, retracting the link 312 pulls on the cuff 310, thereby pullingthe cuff 310 from the cuff pocket 316 and through the lumen 307 alongwith the suture 302, as shown with respect to FIG. 20C.

FIG. 21 shows the pre-tied suture knot 304 disposed about a periphery ofa knot tube 301. In this embodiment, the knot tube 301 includes a hollowcenter 301 a configured to allow passage of an elongate body (not shown)as the suturing device 300 sutures the incision. However, it should benoted that in an alternative embodiment of the present invention, theelongate body (not shown) might also store the suture 302. In thealternative embodiment, the suture 302 and the pre-tied suture knot 304are disposed about a periphery of the elongate body where the pre-tiedsuture knot 304 may reside within a pocket (not shown) of the elongatebody.

Embodiments of the suturing device of the invention may also includeadditional configurations for a foot, as shown with reference to FIGS.22A through 22C. In this embodiment, the suturing device 300 includes afoot 319 having cuff pockets 319 a and 319 b. The configuration of thecuff pockets 319 a hand 319 b allow the foot 319 to hold the cuffs 310and 310′ during use of the suturing device 300. The foot pivots from afirst orientation shown with reference to FIG. 22A to a secondorientation shown with reference to FIG. 22B via a hinge 320 as shown inFIG. 22C.

FIG. 22C shows the hinge 320, which allows rotation of the foot 319 in adirection indicated by directional arrow Y. The hinge 320 may be anydevice capable of rotatably coupling the foot 319 to the suturing device300, such as pin assembly or the like. In addition to the hinge 320, thefoot 319 includes a connector 322 that couples the cuffs 310 and 310′with one another. The connector 322 also includes a flexible portion 322c (shown with respect to FIG. 22C) that allows flexing of the connector322 as the connector 322 resides within passage 317 of the foot 314. Theconnector also includes ends 322 a and 322 b that facilitate connectionwith the penetrator tip 308 and the needle tip 308′ of the elongatebodies 306′ and 306.

In an embodiment of the present invention where the suturing device 300employs the foot 319, during use of the suturing device 300, uponinsertion of the suturing device 300 within the lumen 307, a userdeploys the foot 319 as shown with reference to FIG. 22A. Upondeployment of the foot 319, the user deploys the elongate body 306 (notshown) that engages with the cuff 310 (not shown) as previouslydescribed. Once the penetrator tip 308 detaches from the elongate body306 via the push mandrel 315, or other means previously described, theuser rotates the foot 319 into the orientation shown with reference toFIG. 22B. Upon orientation of the foot 319 as shown with respect to FIG.22B, the user deploys the elongate body 306′ (not shown) which engageswith the cuff 310′ (not shown). After the elongate body 306′ engageswith the cuff 310′, the user retracts the elongate body 306′ along withthe cuffs 310 and 310′ and the suture 302 to suture an incision aspreviously described.

Another embodiment of the suturing device 300 includes feet 324 and 328as shown with reference to FIG. 23A. FIG. 23A illustrates an embodimentof the present invention in which the suturing device 300 includes thefeet 324 and 328. As may be seen with reference to FIG. 23B, the foot324 is hollow such that the foot 328 fits within the foot 324 duringboth insertion and retraction of the suturing device 300 within thelumen 307. The feet 324 and 328 also include cuff pockets 324 a and 328a and cam surfaces 324 b and 328 b. The configuration of the cuffpockets 324 a and 328 a allow placement of the cuffs 310 and 310′ withinthe feet 324 and 328 during use of the suturing device 300; allowingengagement of the elongate bodies 306 and 306′ during suturing. The camsurfaces 324 a and 328 a contact cam surfaces 326 a in order to deploythe feet 324 and 328. Once the feet 324 and 328 deploy, the suturingdevice 300 attains the configuration shown with reference to FIG. 23C.

During use of a suturing device implementing the feet 324 and 328, auser inserts the suturing device into an incision as the foot 328resides within the foot 324. Upon insertion of the suturing devicewithin the incision, the user deploys the feet 324 and 328 by moving thefeet 324 and 328 towards the cam surfaces 326 a, in order to deploy thefeet 324 and 328, as previously described. After deployment of the feet324 and 328 within a lumen, the user deploys the elongate bodies 306 and306′ whereby the penetrator tip 308 and needle tip 308′ engage with thecuffs 310 and 310′ residing within the cuff pockets 324 a and 328 a.Upon engagement with the cuffs 310 and 310′ the user retracts theelongate bodies 306 and 306′ and sutures the incision.

In addition to the alternative configurations for the foot of thesuturing device 300, the suturing device 300 may also includealternative cuff configurations that allow engagement of the elongatebodies 306 and 306′ with the link 312. An example of such an alternativeconfiguration is shown with respect to FIG. 24A. FIG. 24A illustrates aperspective view of an alternative embodiment of the penetrator tip 330.In this embodiment, a penetrator tip 330 includes mating surfaces 330 awhich engage with the previously described cuff tabs 310 a of the cuff310 when the penetrator tip 330 engages with the cuff 310, as shown withreference to FIG. 24B. As such, a user detaches the elongate body 306from the penetrator tip 330 with the push mandrel 315 after engagementof the penetrator tip windows 330 a with the cuff tabs 310, as discussedwith reference to the penetrator tip 308 and the cuff 310. The matingsurfaces 330 a may be cut-outs, such as windows, formed within thepenetrator tip 330. The elongate bodies 306 and 306′ may also engagewith the link 312.

FIG. 25A shows an alternative method of coupling the elongate bodies 306and 306′ with the link 312. In this embodiment, the elongate body 306′includes a loop 332 (shown in FIG. 25B) which engages with the link 312as the elongate body 306′ enters the foot 314. In this embodiment, thelink 312 is constructed of a resilient material capable of flexing inresponse to the loop 332 contacting the link 312, such as polypropyleneor any other material having spring-like characteristics. The elongatebody 306′ moves in a downward direction as indicated by directionalarrow A until the loop 332 comes into contact with an end 312 a of thelink 312. When the loop 332 contacts the end 312 a, the loop 332 movesthe end 312 a in a direction F1 indicated by directional arrow F1. Thecatch 332 continues to move the end 312 a of the link 312 in thedirection F1 until the loop 332 contacts the end 312 a, as shown withreference to FIG. 25B.

Referring to FIGS. 25A-C, the link 312 is constructed of a materialhaving spring like properties. Therefore, when the loop 332 a comes intocontact with the end 312 a, the resilient properties of the link 312move the end 312 a in a direction F2, as indicated by directional arrowF2 in FIG. 25A. The end 312 a moves in the direction F2 such that theend 312 a moves into the loop 332 a, as shown with reference to FIG.25B. Once the end 312 a moves into the loop 332 a, a user retracts theloop 332 along with the end 312 a and the link 312 in a direction B asindicated by directional arrow B of FIG. 25C. As the loop 332 a and thecatch 332 move in the direction B, the loop 332 a clamps the link 312against a surface 306′a of the elongate body 306′. Thus, duringretraction of the suturing device 300 from the foot 314, the link 312remains engaged with the elongate body 306′, as shown with reference toFIG. 25C. As the elongate body 306′ and the catch 332 retract from thefoot 314, the catch 332 pulls the link 312 through the foot 314, also asshown with reference to FIG. 25C. While the catch 332 pulls the link312, the cuff 310 (not shown) and the suture 302 (not shown) movethrough the foot 314 in order to enable suturing of an incision.

In another embodiment, the suturing device 300 may also employ a clipand ring assembly 338 which couples the elongate bodies 306 and 306′with the link 312, as shown with reference to FIG. 26A. FIG. 26Aillustrates a schematic view of the clip and ring assembly 338 forcoupling the elongate bodies 306 and 306′ with the link 312 inaccordance with an embodiment of the present invention. The elongatebodies 306 and 306′ include a clip 336 in place of the penetrator tip308 and the needle tip 308′ where the clip 336 has a configuration asshown with reference to the Figure. The clips 336 include flexible arms336 a and a passageway 336 b.

The clip and ring assembly 338 also includes a ring 334 that engageswith the clip 336. The link 312 couples with the ring 334 using anysuitable technique, such as tying or the like. The ring 334 has acircular configuration as shown with respect to FIG. 26B such that asthe elongate bodies 306 and 306′ engage with the foot 314, the clip 336couples with the ring 334. As the clips 336 engage with the ring 334,the flexible arms 336 a flex in a direction indicated by directionalarrows Y and Z thereby increasing a width Wi of the passageway 336 b inorder to allow passage of the ring 334 through the clip 336 as shownwith regards to FIG. 28C

Referring to FIG. 26D, there is shown a top view of the foot 314 wherethe foot 314 includes cuff pockets 314 b.quadrature.1 and 314b.quadrature.2. The cuff pocket 314 b.quadrature.1 holds the ring 334prior to engagement with the clip 336. The cuff pocket 314b.quadrature.2 is configured such that as the elongate bodies 306 and306′ enter the foot 314, the clips 336 enter the cuff pocket 314b.quadrature.2 and engage with the ring 334 as shown with reference tothe Figure. Once the clip 336 engages with the ring 334, the clip 336coupled with the elongate body 306 detaches from the clip 336 while theelongate body 306′ remains engaged with the clip 336. During refractionof the elongate bodies 306 and 306′ from the foot 314, the elongate body306′ pulls the link 312 and the suture 302 through the foot 314 in orderto suture an incision.

FIG. 27 shows an embodiment of a cuff 410 and link 412 assembly that maybe provide with the various embodiments of the present invention. Cuff411 has a penetrator tip receiving end 434 and a tapered end 432. Link412 has two ends 442 (only one shown in FIG. 27). An example of apreferred link material is expanded Polytetrafluoroethylene (ePTFE).PTFE is commonly referred to as Teflon. ePTFE is particularly suited foruse as the link material in the vessel closure devices described hereinbecause of its low friction, high strength properties.

To assemble the link and cuff assembly, a length of link material isfirst threaded through the cuff. The end of the link material extendingfrom the penetrator tip receiving end 434 of the cuff 410 is then heatedso that it expands. The link is then pull through the cuff 410 such thatthe expanded end portion 442 is seated in the interior tapered end 432of the cuff 410.

The various embodiments of the suturing device may include any of avariety of types of suture, such as braided or monofilament. The suturematerial may be absorbable or nonabsorbable and may be made ofpolyester, polypropylene, polyglycolic acid, nylon, silk or any of avariety of suture materials known in the art. Suture material coatedwith antibiotics or other antimicrobial agents may also be provided withthe suturing devices of the present invention.

An exemplary suture material is TEVDEK II®, a braided polyester suturematerial that is impregnated with PTFE and manufactured by GenzymeBiosurgery of Cambridge, Mass. An exemplary monofilament suture materialis DEKLENE II®, a polypropylene suture material also manufactured byGenzyme Biosurgery. Another exemplary monofilament suture material isnylon monofilament, also manufactured by Genzyme Biosurgery. Whilebraided polyester and monofilament polypropylene or nylon are suitablesuture materials that may be used with the devices of the presentinvention, monofilament suture materials may require post-manufacturingprocessing in order to form the pre-tied knot of the embodimentsdescribed with reference to FIGS. 11A through 11E and 14A through 21.

Monofilament suture material tends to be stiffer relative to braidedsuture material. As such, forming a bight of suture for the purpose ofproviding a pre-tied knot is more difficult with monofilament suturethan with the more flexible braided suture. The monofilament suturematerial will tend to straighten itself out after being looped to form abight 80 (shown in FIGS. 11Ai and 11Aii). Therefore, in order to providea bight of monofilament suture that is releasably disposed on the shaftof the device without unravelling, such as shown in FIGS. 11Ai and11Aii, FIG. 15A (pre-tied knot 104), and FIG. 21 (pre-tied knot 304),the loops forming the bight are heated to set the bight. The heating ofthe bight of monofilament suture to set the bight is performed after thesuture has undergone any manufacturing procedures that may includedrawing, annealling or any other procedure that employs heat tomanufacture the suture material.

A method of forming a pre-tied knot for a suturing device of the presentinvention includes providing a length of monofilament suture having afirst end, wrapping a portion of the length of monofilament suturearound a mandrel to form a looped configuration spaced from the firstend, and heating the wrapped portion to a temperature below the meltingpoint of the monofilament suture such that upon removal of the mandrel,the wrapped portion remains in the looped configuration.

The bight of the suture includes at least one loop. The heating of theat least one loop is performed to set the bight in the loopedconfiguration. The temperature is kept below the melting temperature ofthe suture material, yet is selected to cause the suture to remain inthe formed looped configuration after the bight is removed from theheat. The temperature is selected so as not to adversely affectproperties such as strength of the suture.

In one exemplary heating process, a length of size 3/0 polypropylenesuture is looped around a mandrel to form a bight which is heated at atemperature between about 240° Fahrenheit to about 260° F., or nominallyabout 250° F., for about 3 to about 5 seconds. The heat is provided by ablowing heat source such as a heat gun that provides an air flow at arate of about 10 to about 30 standard cubic feet per hour (scfh), ornominally about 20 scfh. The heating of the formed bight may beaccomplished in an oven that is heated to about 200° Fahrenheit to about280° F. When the bight is formed using an oven, the amount time that thebight is held in the heat of the oven is approximately 1 minute to about15 minutes. The specific heating temperatures and times may be selectedas appropriate for different suture sizes or types, or different typesof bight configurations

In another embodiment, a monofilament nylon suture material may beprovided to form a pre-tied knot in a suturing device of the presentinvention. The temperature at which a bight formed with size 3/0 nylonsuture is heated to set the bight is about 190° F. to about 210° F., andnominally about 200° F., for about 3 to about 5 minutes with a blowingheat source such as a heat gun. In an oven, the temperature used atwhich the bight is set is about 190 to about 210, or nominally about200° F. for about 1 minute to about 15 minutes.

FIG. 28 shows a bight 580 of monofilament suture wrapped around amandrel 589 in preparation for heating the loops of the bight to set thebight. The mandrel may be a polyimide shaft or tube having a diameter ofabout 0.65 mm, for example. In the example shown in FIG. 28, the sutureis size 3/0 and is wrapped to form a looped configuration which definesa clinch knot. To wrap the suture as shown in FIG. 28, a length ofsuture is held against the mandrel with a first end 576 oriented acrossthe mandrel. The second end of the length of suture is wrapped fivetimes around the mandrel. The second end is then wrapped over the firstend to form loop 590 transverse to the first five loops. The second endis then looped behind the mandrel and wrapped over the mandrel in theopposite direction from the first five loops. The second end is thenrouted through loop 590 to form the pre-arranged or pre-tied knot.

FIG. 29 illustrates another embodiment of the present invention furtherincluding a pre-tied knot 100 of suture disposed around shaft 12.Needles 38 each have detachable needle tips 78 attached to the ends ofthe needles. Detachable needle tips 78 each have opposite ends of suture34 affixed thereto. Bight 80 is prearranged to define the pre-tied knot100 when an end of the suture 34 passes therethrough, as described abovewith reference to FIGS. 11A to 11E. An exemplary knot was described withreference to FIG. 11Aii, above. It should be noted that bight 80 willoften include more than one loop, and may be prearranged to define avariety of known or new knots.

In operation, needles 38 each carry an opposite end of suture 34 towardfoot 24 after foot 24 has been deployed (as shown). Each needle 38includes a detachable tip 78 such that when needles 38 are advancedthrough tissue and into receptacles 52 in into receptacles 52. Thedetachable tips 78 are then detached from the needles 38 by pushmandrels (not shown) from inside the hollow needles, for example.Alternatively, tips 78 may be frictionally or mechanically held withinreceptacles 52 such that they are pulled off the needles 38 uponretraction of the needles from the foot. Needles 38, without tips 78,are then retracted back up into shaft 12, and foot 24 carrying tips 78with suture 34 ends is then rotated back into a non-deployed position.

When shaft 12 is removed from the patient's body, foot 24 is in itsundeployed position, and the ends of the suture 34 are adjacent thecentral axis of the shaft 12. Pre-tied knot 100 will then slide downshaft 12, over the ends of the suture 34, resulting in the suturepattern as shown in FIG. 30 in which the opposite ends of suture 34 passupwardly through the bight 80 to form the pre-tied knot 100.

FIG. 31 illustrates another embodiment of the present invention alsoincluding a pre-tied knot 100 of suture disposed around shaft 12, asfollows. Needle 38A carries one end of suture 34. A detachable tip 78 isdisposed on the end of needle 38A. The detachable tip 78 is connected tothe suture end 76 (similar to end 76 of suture 34 shown in FIG. 11A).Additionally, connecting filament 74 is provided on foot 24, asdescribed above.

In operation, needle 38A carries one end 76 of suture 34 toward foot 24after foot 24 has been deployed (as shown). Needle 38A includes adetachable tip 78 such that when needles 38A and 38B are advanced intoreceptacles 52 in foot 24, the end 76 of suture 34 is connected to oneend of the connecting filament 74. Needle 38B is connected to the otherend of the connecting filament 74. Needles 38A and 38B are thenrefracted back into shaft 12, and foot 24 is then rotated back into anon-deployed position. As needle 38A is retracted, tip 78 and suture end76 are detached from the shank of needle 38A. Needle 38B is engaged withthe connecting filament 74, which in turn is engaged with detachable tip78. Suture end 76 is affixed to tip 78. Thus, as needle 38B iswithdrawn, it passes up into shaft 12, through the center of bight 80 toform pre-tied knot 100 by pulling connecting filament 74 and suture end76 through bight 80.

When shaft 12 is removed from the patient's body, pre-tied knot 100 willthen slide down shaft 12, resulting in the suture pattern as shown inFIG. 32 in which the end 76 of suture 34 passes upwardly through thebight 80.

The suture pattern formed by the pre-tied knot in FIG. 32 is differentfrom that of FIG. 30. Specifically, in FIG. 30, the opposite ends ofsuture 34 both pass outwardly through puncture P, whereas in the suturepattern shown in FIG. 32, the opposite ends of suture 34 do not passthrough the puncture P, but rather through the vessel wall adjacent thepuncture.

FIG. 33 illustrates yet another embodiment of the present invention alsoincluding a pre-tied knot 100 disposed around shaft 12, as follows. Eachof the opposite ends of the suture 34 are positioned in receptacles 52.Needles 38 are advanced downwardly after foot 24 has been deployed (asshown) such that each of needles 38 become connected to an opposite endof suture 34 at the locations of receptacles 52. For ease ofillustration, specific details of connections are not shown in FIG. 33.However, an example of a system suitable for connecting a needle 38 toan end of suture 34 is described above in FIG. 4.

After needles 38 have been connected to opposite ends of suture 34,needles 38 are then both retracted up into lumens in shaft 12, therebypulling the opposite ends of suture 34 up through shaft 12, and throughthe bight 80 of suture to define the pre-tied knot 100 (which isinitially disposed around the outer surface of shaft 12, as shown).

When shaft 12 is removed from the patient's body, pre-tied knot 100 willthen slide down shaft 12, resulting in the suture pattern as shown inFIG. 34 in which the opposite ends of suture 34 pass upwardly throughthe center of knot 100, as shown.

The suture pattern in FIG. 34 is slightly different from that of FIG.30, although both FIGS. 30 and 34 show the opposite ends of suture 34passing through the center of the bight 80 to form the knot 100.Specifically, when forming the suture pattern of FIG. 30, the oppositeends of suture 34 were both passed down through the tissue wall W, andthen up through puncture P; whereas, when forming the suture pattern ofFIG. 34, the opposite ends of suture 34 were both passed down throughpuncture P, and then up through tissue wall W, and further through bight80 to form knot 100

FIG. 35 is an illustration of a suturing device 220 similar to anembodiment shown in U.S. Pat. No. 6,245,079, but also incorporating thepre-tied knot of the present invention. U.S. Pat. No. 6,245,079 isincorporated herein by reference in its entirety.

As can be seen in FIG. 35, a suture introducer head 222 having a hollowbody 214 with needles 246 therein is provided. Flexible needles 246 bendoutward, away from the axis of the device, when in the extendedposition.

The hollow body 214 has two needle ports or apertures 210 formed therein(one per needle 246) proximal to the suture clasp arms 224. Each sutureclasp arm 224 is moved to the retracted position by applying a force tothe actuator rod (not shown) within the body 214 if the device. Thesuture clasp arms 224 hold the looped ends of a suture 34 in needleretaining portions 225.

The needles 246 slide out of the suture device 220 through needleapertures 210. Needles 246 bend radially outwardly to penetrate thevessel wall (not shown) on either side of the puncture.

The suture catches 238 on the needles 246 catch the suture loops 35 heldby the suture clasp arms 224 and pull the ends of the suture 34 upthrough the punctured holes when the needles 246 are refractedproximally. When the needles 246 are refracted into the needle lumens(not shown), they resume a straight configuration.

In accordance with the present invention, suture bight 80 is disposed onthe outside surface of the housing with a center portion of bight 80comprising a pre-tied knot 100 that is wrapped around the outside ofdevice 220, as shown. In this embodiment, suture 34 does not passthrough the interior of the device shown in FIG. 35. It should beunderstood, however, that other embodiments of the invention may includethe suture 34 and bight 80 stored inside the shaft or housing of thedevice rather than on the outside. Yet other configurations may includethe detachable tips or link features described above with respect topreviously described embodiments.

After needles 246 retrieve opposite ends of suture 34, and pull theseends of the suture back up through the center of bight 80 to define thepre-tied knot 100, and suture clasp arms 224 are rotated back to anon-deployed position, device 220 may be removed from the patient.Pre-tied knot 100 will slide down the shaft, resulting in the samesuture pattern as shown in FIG. 34, in which the opposite ends of suture34 pass upwardly through the center of bight 80

FIGS. 36 through 38 are illustrations of a device as shown in U.S. Pat.No. 5,613,974 incorporating the pre-tied knot of the present invention.U.S. Pat. No. 5,613,974 is incorporated herein by reference in itsentirety.

FIG. 36 shows a suturing device 310 comprises a guide body 312, a needleguide 314 secured to a distal end of the guide body 312, and a flexibleneedle sheath 316 secured to the distal end of the needle guide 314.Tissue receiving region 346 is defined by needle guide 314 and thedistal face of guide body 312. Needles 320 are mounted with their distalends in a holster attached to a reciprocatable shaft (not shown). Handle328 can be pulled proximally in order to draw the needles 320 from thesheath 316, through the needle guide 314, and into the guide body 312.Moreover, suturing device 310 is provided with the capability ofdelivering a pre-tied suture knot 100.

Guide body 312, needle guide 314, flexible needle sheath 316, needles320, tissue-receiving region 346 and handle 328 correspond generally toguide body 12, needle guide 14, flexible needle sheath 16, needles 20,tissue-receiving region 346 and handle 28 in U.S. Pat. No. 5,613,974.

Referring to FIG. 36, opposite ends of suture 34 are each connected tothe ends of needles 320. Bight 80 is disposed around guide body 312, andis prearranged to define a pre-tied knot 100 when ends of the suture 34pass therethrough. Bight 80 may include one or more loops of suture 34,and may be prearranged to define a variety of known or new knots.

Further details of the positioning of suture 34 are shown in FIG. 37.After needles 320 have been deployed proximally through a layer oftissue T and received into lumens in guide body 312, bight 80 will slipdown the shaft of the device and form a suture pattern similar to or thesame as that illustrated in FIG. 30, wherein the ends of suture 34 arepassed through the loop or loops of bight 80 to form a pre-tied knot.

FIG. 38 shows suturing device 310 including a modified arrangement ofbight 80. Bight 80 includes a first portion 80A prearranged in thetissue receiving region 346 and a second portion 80B prearranged on theguide body 312. The bight 80, including first portion 80A and secondportion 80B, is prearranged to define a pre-tied knot 100 when ends ofthe suture 34 pass therethrough. Bight 80 may include one or more loopsof suture 34, and may be prearranged to define a variety of known or newknots.

FIG. 39 shows the arrangement of bight 80 on the device. To wrap bight80 around the tissue receiving region 346 and the guide body 312 in amodified “figure eight” configuration, a temporary pin 313 is providedto hold the intermediate portions of the loops forming bight 80 in placewhile the loops forming first portion 80A and second portion 80B arewrapped. Once the bight 80 is in position on the device, the pin 313 isremoved and the bight 80 is held on the body of the device with adhesiveor a covering such as shrink wrap tubing (not shown). During deploymentof the device, the needles 320 carry respective first and second ends ofthe length of suture 34 over the first portion 80A of the bight 80 andinto the guide body 312.

FIG. 40 shows a schematic view of the suture 34 and needle 320 assembly,wherein the bight 80 is laid out flat for ease of viewing the routing ofthe suture loops forming bight 80. First portion 80A is shown encirclinga cross-sectional representation of the tissue receiving region 346.Second portion 80B is shown encircling a cross-sectional representationof the guide body 312. Needle receiving lumens 372 are defined throughthe guide body 312. Bight 80 can be visualized as being folded alonglines A and B of FIG. 40 when bight 80 is prearranged on the body of thedevice.

FIG. 41 shows a pre-tied knot 100 deployed in a wall W of tissue such asa blood vessel wall. Pre-tied knot 100 is the result of deployment ofthe device and suture bight 80 arrangement shown in FIGS. 23, 24A, and24B.

FIGS. 42 through 46 show additional embodiments of the invention inwhich a suturing device as shown in U.S. Pat. No. 6,436,109 or in U.S.Pat. No. 6,451,031 incorporates a pre-tied knot. Specifically, FIGS. 42through 44 show one embodiment of such a device, and FIGS. 45 and 46show another embodiment of such a device. U.S. Pat. No. 6,436,109 andU.S. Pat. No. 6,451,031 are incorporated herein by reference in theirentirety.

FIGS. 42 and 45 show a suturing device 401 that includes a tube 416 ofcircular or substantially circular cross-section. Tube 416 has aproximal portion 418 and a distal portion 424. The proximal portion 418extends from a first end 420 to a connecting portion 422. Proximalportion 418 has a first needle lumen (not shown) extending therethroughto a first needle opening 410. Distal portion 424 extends distally fromthe connecting portion 422. Referring to FIG. 43, distal portion 424includes a second needle opening 433 facing the first needle opening 410across a tissue receiving gap 426, which is defined by the connectingportion 422. The second needle opening 433 opens into a second needlelumen (not shown).

Referring again to FIGS. 42 and 45, the connecting portion 422 has anarcuate shape and is coupled between the proximal portion 418 and thedistal portion 424. The connecting portion 422 is offset from theproximal and distal portions to create the tissue receiving gap 426.When the connecting portion is received within a puncture in ananatomical structure, a portion of the anatomical structure receivedwithin the tissue receiving gap is located on one side of a planeincluding a central axis of the puncture.

Referring to FIGS. 42 and 43, suture 34 includes a bight 80 of suturethat is disposed around the second needle opening 433 (FIG. 43). In thisaspect of the invention, each of the needles is connected to oppositeends of suture 34. In operation, needles 437A and 437B (FIG. 42) aresequentially advanced out of first needle opening 410, across gap 426,and into second needle opening 433.

Bight 80 is prearranged to define a pre-tied knot 100 (FIG. 43) when atleast one end of suture 34 passes therethrough. Bight 80 may includemore than one loop, and may be prearranged to define a variety of knownor new knots.

FIGS. 44A through 44D are schematic views showing the sequence ofdeployment of needles 437A and 437B and suture through bight 80 relativeto the tissue wall W having the puncture P which is to be closed. Thissequence illustrates the operation of the embodiment of the pre-tiedknot shown in FIGS. 42 and 43.

FIG. 44A shows the bight 80 positioned below the tissue wall W. Needle437A has been advanced through tissue wall W adjacent puncture P tocarry an end of suture 34 through the bight 80.

FIG. 44B shows the bight 80 positioned on the opposite side of thepuncture P. Second needle 437B has been advanced through tissue wall Wadjacent puncture P to carry an end of suture 34 through the bight 80.At this stage, both needles 437A and 437B are disposed in the distalportion of the device (not shown for simplicity of explanation).

FIG. 44C shows the position of the bight 80 and needles 437A and 437Bafter the device (not shown) has been withdrawn proximally through thepuncture P. FIG. 44D shows the final position of the pre-tied knot 100after having been advanced and cinched to close the puncture P.

Referring to FIGS. 45 and 46, the bight 80 is disposed around connectingportion 422. In this aspect of the invention, each of needles 437A and437B is connected to opposite ends of suture 34. In operation, needles437A and 437B are sequentially advanced out of first needle opening 410,across connecting portion 422, and into second needle opening 433.Needles 437A and 437B pass over bight 80 (FIG. 46) as they cross thetissue receiving gap 426 while advancing distally from proximal portion418 to distal portion 424.

After device 401 has been removed from the patient's body, bight 80 willthen slide down over connecting portion 422 and distal end portion 424such that the ends of the suture 34 are passed through bight 80 to forma pre-tied knot 100.

The present invention offers surgeons an automated method for deliveringa pre-tied knot to an incision formed in a lumen. The present inventionminimizes the problems associated with a surgeon manually delivering aknot to an incision site. Thus, the present invention reduces the timerequired to accurately and precisely place a suture knot in closeproximity to an incision formed in a lumen, thereby decreasing both theoverall time a patient spends in procedure and the costs associated withthe procedure.

While the exemplary embodiments have been described in some detail forclarity of understanding, a wide variety of modifications, adaptations,and changes will be apparent to those of skill in the art. Hence, thescope of the present invention is limited solely by the appended claims.

1. A method for suturing a vessel through a puncture and a tissue tract,the method comprising: inserting a suturing device along the tissuetract and into the vessel through the puncture, the suturing devicecomprising: a probe suitable for insertion along the tissue tract andinto the vessel through the puncture; at least one penetrator disposedwithin a portion of said probe, said at least one penetrator cooperatingwith a length of suture, said length of suture including a pre-tiedknot; and an actuator cooperating with said at least one penetrator,said actuator being movable within said probe to deploy said at leastone penetrator, said at least one penetrator becoming detached fromwithin said portion of said suturing device.
 2. The method as recited inclaim 1, wherein the suturing device further comprises at least one footmovably mounted to the probe.
 3. The method as recited in claim 2,wherein said probe further comprises a shaft, said at least one movablefoot being movably mounted to said shaft.
 4. The method as recited inclaim 1, wherein said at least one penetrator comprises a detachabletip, said detachable tip being detachable from within said first portionof said probe.
 5. The method as recited in claim 1, said pre-tied knotbeing disposed to receive an end of said length of suture.
 6. The methodas recited in claim 1, wherein said at least one penetrator is disposedproximal to a distal end of said probe.
 7. The method as recited inclaim 1, wherein said at least one penetrator comprises a hollow needle.8. A method for suturing a wall of a vessel through a puncture and atissue tract, the method comprising: inserting a suturing device alongthe tissue tract and into the vessel through the puncture, the suturingdevice comprising: a probe suitable for insertion along the tissue tractand into the vessel through the puncture; at least one detachablepenetrator disposed within a first portion of said probe, said at leastone detachable penetrator being detachable from within said firstportion of said probe; an actuator cooperating with said at least onedetachable penetrator, said actuator being movable within said probe todeploy said at least one detachable penetrator; and at least oneflexible filament cooperating with said at least one detachablepenetrator so that at least a portion of said at least one flexiblefilament passes through the wall of the vessel and is received by apre-tied knot said at least one flexible filament, said pre-tied knotbeing disposed about an outer surface of said suturing device.
 9. Themethod as recited in claim 8, wherein said at least one penetratorcomprises a detachable tip, said detachable tip being detachable fromwithin said first portion of said probe.
 10. The method as recited inclaim 8, said pre-tied knot being disposed to receive an end of said atleast one flexible filament.
 11. The method as recited in claim 10,wherein said bight of suture is disposed within a slot formed in anexterior surface of said probe.
 12. The method as recited in claim 8,wherein said at least one flexible filament comprises a first length ofsuture extending from said at least one detachable penetrator.
 13. Themethod as recited in claim 8, wherein said at least one flexiblefilament comprises: a first length of suture extending from said atleast one detachable penetrator; and a second length of suture extendingfrom a receptacle supported by said probe, said receptacle receivingsaid at least one detachable penetrator.
 14. A method for suturing awall of a body lumen through a puncture and a tissue tract, the methodcomprising: inserting a suturing device along the tissue tract and intothe vessel through the puncture, the suturing device comprising: a probesuitable for insertion along the tissue tract and into the body lumenthrough the puncture; two needles disposed within a portion of saidprobe; an actuator cooperating with said two needles, said actuatorbeing movable within said probe to deploy said two needles into the bodylumen, a portion of at least one of said two needles detachable fromwithin said portion of said probe upon being disposed within the bodylumen, wherein deploying said at least one of said two needles carriessaid length of suture through the wall of the body lumen and into thebody lumen, said length of suture including a pre-tied knot disposedabout an outer surface of said suturing device.
 15. The method asrecited in claim 14, wherein the suturing device further comprises atleast one foot movably mounted to the probe.
 16. The method as recitedin claim 15, wherein said probe further comprises a shaft, said at leastone movable foot being movably mounted to the said shaft.
 17. The methodas recited in claim 14, wherein said at least one of the two needlescomprises a detachable tip, said detachable tip being detachable fromwithin a first portion of said probe.
 18. The method as recited in claim14, said pre-tied knot being disposed to receive an end of said lengthof suture.
 19. The method as recited in claim 14, wherein each of saidtwo needles comprises a detachable tip.
 20. The method as recited inclaim 14, wherein at least one of said two needles comprises a hollowneedle.